- -Lead compound selectively and directly inhibits XBP1s
- -Supported by research funding for two years, advancing to an oral first-in-class anticancer drug candidate
- -Expected to show antitumor effects in patients resistant to standard hormone therapy
- -Discovered through AI-based R&D platform CLOVER, continuously generating new drug candidates in oncology and immunological diseases
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June 2024
JW Pharmaceutical (CEO Shin Young-seop) announced on the 25th that its subsidiary, C&C Research Laboratories (CEO Park Chan-hee), has been selected for the "2024 1st National New Drug Development Project for Building a New Drug R&D Ecosystem" to develop a treatment for hormone-resistant and non-responsive prostate cancer.
The National New Drug Development Project is an interagency national R&D initiative launched to strengthen the global competitiveness of the domestic pharmaceutical and biotechnology industries. The National New Drug Development Project Team (led by Director Park Young-min, hereafter referred to as 'the team') aims to support all phases of new drug development from 2021 to 2031, enhancing the domestic new drug R&D ecosystem, creating globally practical outcomes, and generating public health benefits.
Over the next two years, C&C Research Laboratories will receive research funding from the team to optimize a lead compound that directly inhibits XBP1s and develop an oral first-in-class anticancer drug candidate.
XBP1s is a protein that is highly expressed in various solid tumors, playing a crucial role in cancer proliferation. Specifically, XBP1s increases the activity of genes related to cancer cell survival, diminishing the efficacy of standard treatments and enabling cancer cells to evade immune responses.
The lead compound selected for this project was discovered through the institute's proprietary data science platform, CLOVER, which combines chemical and biological informatics big data with AI and deep learning technologies.
This lead compound demonstrated excellent anticancer effects by directly binding to and inhibiting the XBP1s protein in cell experiments, and showed tumor suppression effects. It also exhibited superior antitumor efficacy in drug response measurements in prostate cancer animal models compared to control groups.
C&C Research Laboratories plans to conduct structural optimization research on the XBP1s-targeted anticancer lead compound and derive a preclinical new drug candidate by 2025.
A representative from JW Pharmaceutical stated, "Prostate cancer, the second most common cancer in men, has a high demand for innovative drugs with new mechanisms of action due to resistance and non-responsiveness to first-line standard hormone therapies. We aim to develop the lead compound targeting XBP1s into an innovative anticancer drug that can overcome the limitations of existing treatments not only for prostate cancer but also for various solid tumors."
C&C Research Laboratories, established in 1992 as the first Korea-Japan joint venture bioventure by JW Pharmaceutical and Chugai Pharmaceutical, a member of the Roche Group, became a 100% subsidiary of JW Pharmaceutical in 2020. Since 2010, C&C Research Laboratories has been discovering innovative drug candidates through its R&D platform, CLOVER, which integrates AI and deep learning technologies with chemical and biological informatics big data. It currently holds a pipeline of over 10 new drug candidates for oncology and immunological diseases, including gout treatment 'Epaminurad (URC102)', atopic dermatitis treatment 'Ezzofrant (JW1601)', and STAT3-targeted anticancer drug 'JW2286', all of which have been licensed to JW Pharmaceutical. The institute is also focusing on developing new drugs targeting STAT proteins that regulate cell growth, mutation, and proliferation, alongside its XBP1s-targeted research.
C&C Research Laboratories' new drug pipeline has been continuously recognized as a national project by the team. In 2021, the institute was selected for the lead compound optimization research for a STAT3-targeted atopic dermatitis treatment, in 2022 for the preclinical research of the STAT3-targeted anticancer drug JW2286, and in 2023 for the lead compound optimization research for a STAT5/STAT3 dual-targeted acute myeloid leukemia treatment.
About Prostate Cancer and the Market
Prostate cancer is a malignant tumor that develops in the prostate gland cells and is the second most frequently diagnosed cancer in men worldwide. Its incidence increases with age, and while early-stage disease progresses slowly with a five-year survival rate of 97.1%, the survival rate for metastatic prostate cancer drops sharply to 34.1%. Prostate cancer is often asymptomatic in its early stages, making detection difficult, but as it progresses, symptoms such as urinary abnormalities, testicular pain, and erectile dysfunction may appear.
The primary treatment, hormone therapy, is initially effective but most patients develop resistance within 18-24 months, leading to recurrence. This creates a high unmet medical need for new therapies.
Globally, while the incidence of prostate cancer is decreasing or stabilizing, the number of diagnosed patients is expected to increase due to population aging. According to "Datamonitor Healthcare" in 2023, approximately 597,440 people were diagnosed with prostate cancer worldwide in 2022, and this number is projected to rise to about 681,600 by 2032.
The global prostate cancer treatment market is expected to grow from $10.667 billion in 2022 to over $19.998 billion by 2032, reflecting a compound annual growth rate (CAGR) of 6.5%.
About XBP1s
XBP1s (X-Box-binding Protein 1 splicing form) is a protein activated by endoplasmic reticulum (ER) stress and androgen receptor (AR) signaling, known to play a critical role in the proliferation of various solid tumors. High ER stress and increased expression of XBP1s are common in patients resistant to standard treatments, making it a major cause of drug resistance.
XBP1s increases the activity of genes related to cancer cell survival, rendering standard treatments ineffective and further weakening the efficacy of drugs by inhibiting immune cells' anticancer responses, allowing cancer cells to evade immune attacks. Currently, there are no clinically developed XBP1s inhibitors as anticancer drugs worldwide.
Therefore, JW Pharmaceutical expects that C&C Research Laboratories' XBP1s inhibitor will be developed as a new targeted therapy providing both anticancer effects and immune modulation for patients resistant to standard treatments.